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Device | SPINALPAK(R) STIMULATOR |
Generic Name | Stimulator, bone growth, non-invasive |
Applicant | EBI, LLC a Highridge Medical Company 1 Gatehall Drive Suite 303 Parsippany, NJ 07054 |
PMA Number | P850022 |
Supplement Number | S009 |
Date Received | 03/13/1997 |
Decision Date | 09/24/1999 |
Product Code |
LOF |
Docket Number | 00M-0901 |
Advisory Committee |
Orthopedic |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for SpinalPak Bone Growth Stimulator. The device is indicated as a noninvasive bone growth stimulator for use as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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